The Art of Project Management for Pharma Projects

Managing the technical challenges of pharma and biotech industry projects

This 2-day seminar gives you a practical approach to managing the technical challenges in typical pharmaceutical and biotech industry projects so that you can more effectively deal with the deadlines, resource needs, and technical complexities.

The course focuses on project initiating, planning, executing, controlling, reporting and closing and is based on the five basic functions of project management: Planning, Organizing and Staffing, Directing and Leading, Controlling and Reporting.

Classic project management tools are presented in a new light through high energy lectures. Participants then work in teams to design a variety of Work Breakdown Structures, Network Diagrams, Gantt Charts, Budgets and Risk Plans for different project situations. Participants learn simple, effective techniques to measure projectj performance and control and report on project status.

The course references project management processes found in the PMBOK® Guide 5th Edition of the Project Management Institute.

Learning outcomes

Identify issues and opportunities related to the CRO

Plan, structure and organize a pharmaceutical project

Use simple and effective project risk management techniques

Organize and staff your project

Lead and direct your project team effectively

Control project performance

Develop reports

Learn about best practices from R&D and medical devices projects

Topics

The Project Management Method

Cross-functional pharmaceutical project teams

Decentralized responsibility and authority

Building commitment and ownership of team members

A project as a way to get work done

Management functions, roles, responsibilities

Effect of national, corporate, and personal cultures/values

What makes clinical trial projects different?

Project and Line Management interfaces

Exercise: Identifying issues and opportunities related to the CRO

Presentation of best practices for managing critical contract services and CRO's for developing a sense of ownership and commitment among project team members who come to the project with various specialties and functions.

Exercise: The Assessment Inventory of Project Management and Action Planning Kit™. Participants will use this unique 360 degree evaluation tool to benchmark and improve their project management skills

Project Planning

Project tools used to initiate and plan the pharmaceutical project

Sorting out and defining client (and stakeholder) requirements

Value of verifiable project objectives

Task assignments and requests

Statement of Work (SOW)

Work Breakdown Structure (WBS)

Project organization and Linear Responsibility Charts (LRC)

Scheduling the Project work; Gantt, PERT, CPM

Resource requirements and personnel assignment planning

Procurement and contracting methods and practices

The performance baseline, project budget

Presenting the Project Execution Plan

Workshop: Structuring and organizing a pharmaceutical project: Participants share their experiences and apply the techniques to project plans and performance baselines for their projects. They evaluate the strengths and weaknesses of their approaches based on the information learned in the course.

Project Risk Management

Responsibilities of the project leader and project team for risk

International definition of risk terminology, and concepts

Development of a Risk Management Plan for the pharmaceutical project

Techniques to identify risk, evaluate the probability and severity of risk, decide mitigating risk response, consider risk as an advantage, and develop a risk monitoring plan

Workshop: The "Fine" Project: Participants apply control concepts to a typical laboratory task.

Reporting

Using reporting systems with team and client communications

How often, and how to create reporting for project progress

Keeping the client informed-project status review principles

How to design the reporting system

Control reports samples

Workshop: Creating a Management Reporting System for Project Control: Participants are grouped into teams to develop what they believe, based on the principles of practical project control, to be the appropriate reporting methods, formats and information required to best control pharmaceutical, clinical, R&D and medical devices projects

Project Closing

Facilitation of closure

Professional Responsibility

Exercise: Matching the Project Management Methodology techniques learnt to the issues and problems identified earlier in the course

Develop an Action Plan

Information

Course Code

-

Department

Vocational Training

Instructor

Dr. Mary Danone, PMP

Instruction Languages

EN

Level

Intermediate

Prerequisites

Basic project management knowledge is recommended.

Who should attend

project managers, project leaders, team members and senior executives involved in the planning and executing of pharma projects